Examination of Witnesses (Questions 60-79)
4 MARCH 2004
LORD WARNER,
MR MILES
AYLING, MRS
ANNE RAINSBERRY
AND DR
CHARLES DOBSON
Q60 Mr Burns: It sounded like that.
Lord Warner: Possibly I was giving
a complicated answer which may have made you think that, but I
was giving—
Q61 Mr Burns: It seemed very clear.
Lord Warner: I thought I was being
very clear.
Q62 Mr Burns: You said that PCTs
had money so that there was not a problem with consideration of
the finances in taking the decisions on IVF, for example.
Lord Warner: Would you like me
to have another go?
Q63 Mr Burns: Go on then.
Lord Warner: What I was saying
was that we are in the middle of a five-year period when NHS budgets
are going up by 7-7.5% in real terms. Those are very substantial
increases. We are agreed on that.
Q64 Mr Burns: We got that.
Lord Warner: Seventy five per
cent of that money is at the disposal of PCTs, so not at the disposal
of the Secretary of State, not at the disposal of the SHAs. It
is in the hands of the PCTs. NICE guidance itself has variable
impact in different parts of the country to do with what the demographics
of that particular part of the country are, almost by definition,
because some people have got more elderly people, others have
less, some people have got more younger people where women would
be at the age for possible fertility treatment and others have
less, so there are variations in the socio-demographic profile
of the PCTs. The system works on the basis that they make the
judgment in the light of their local priorities and their populations
on how they spend their money. Those are the rules of the game.
In that context what I was saying as a general point was that
if you put that amount of money into the system, 7-7.5% real terms
increase over five years, and you look at the total cost of the
NICE recommendations, there is no reason for thinking as a general
proposition that money is a factor because there is enough money
in the system to implement those NICE guidelines. That is the
position of the Secretary of State and it is the position of me
and it is the position of the government on this issue. I am not
saying that within particular areas there may not be some difficult
judgments to be made about the priorities on which they spend
their money.
Mr Burns: I think you are absolutely
right on that, but that is not what you said the first time round.
Q65 Mr Burstow: Taking it on a step
further from that answer, the implication of what you were saying
to Dr Taylor earlier on was that there are capacity bottlenecks
within the system that make it impossible for three cycles of
IVF to be introduced on the timescale that would normally be applied
to the introduction of such guidance. Can you identify what those
bottlenecks are, how widespread they are and how soon they will
be overcome?
Lord Warner: I have not got the
details of the NICE report with me but my memory of it was that
NICE themselves recognised that there were implementation
issues so that, even if you wished it, you could not simply overnight
introduce three cycles, not least because in many parts of the
country there are already waiting lists for people wanting to
access IVF. Those waiting lists would not simply disappear overnight
just because NICE had produced their guidance, so there is a people
capacity issue about their capacity to do that. There are also,
which I think may influence people's judgment about what the costs
are, differences of view probably about whether, if there was
NICE guidance for three, you would not actually increase demand
as well. There is some evidence base, I think, to suggest that
all the while that there is not any NICE guidance there is probably
some unmet demand in the system, so even if you just announce
that one is going to be available everywhere on the NHS, you are
probably putting up demand, so you would be facing NHS providers
with a growing demand and existing waiting lists. In those circumstances
you cannot magically increase the number of staff that quickly
to meet those two pressures. That is the thinking behind this.
Q66 Mr Burstow: That is useful, and
if it is possible for you to amplify that a little further in
writing it would be very helpful to identify further the rationale.
Can you say a little bit as to why that process and the advice
that ministers received that led to the decision by the Secretary
of State to say that it should be limited to one cycle and whether
or not a view was taken as to at what point in time it would be
reasonable to say that the NHS should be delivering three cycles,
because that has not been said yet and yet that means there are
many people in the country who feel to some extent that they see
themselves not able to get access to the treatment they want and
certainly not access to the treatment that NICE said they should
have?
Lord Warner: I do not think we
can anticipate that, mainly for the reasons that I have just given.
What we are doing is encouraging all PCTs to make one cycle available
throughout the NHS and we need to wait and see how they get on
with that and see how things work. There are the resource constraints
that I have mentioned. It is worth bearing in mind that even on
one cycle the success rate is estimated to be that about 25% of
the women get pregnant, so that in itself will bring quite a lot
of success in quite a lot of cases.
Q67 Mr Burstow: Would you be concerned
if some PCTs who offered more than one cycle already levelled
down to the recommendation by the Secretary of State and only
had one cycle?
Lord Warner: We are back to the
earlier discussion about PCTs making judgments about their priorities
in their local areas. What we cannot do is have it both ways.
You are either running a devolved NHS with a lot of local people
making their decisions which, if I may say so, I understood your
party to be in favour of, or you say, "We are going to try
and control everything from Richmond House".
Q68 Dr Taylor: I think we will move
on from IVF, but just a quick comment on the money side. I do
understand and welcome the vast extra investment. It is the distribution
that is so difficult because I am sure many of us see our own
counties in really quite massive deficit and it is hard to know
where the extra money is, but I take that. Moving on, one of the
other things that our report on NICE recommended was a change
in the appeals process because we were rather concerned that the
Chair of the Institute was the Chair of the Appeals Committee.
He made it quite clear that because he was not taking active part
in the actual inquiries he was therefore distant from them, but
the government recommendation was that a change should be made.
I wonder if that change has been made?
Lord Warner: I am going to ask
Dr Charles Dobson to speak on this.
Dr Dobson: NICE have always been
very clear that they see the appeals process as an integral part
of the whole appraisal process. It is as it were part of the remedies
available to interested parties who are not happy with the initial
judgments. They have also consistently taken the line that it
would be quite wrong for the appeals process to be too separate
from NICE because that would in effect create two separate sources
of advice to the NHS, NICE itself and the supposedly independent
appeals process, so they have always very clearly taken the view
that the appeals process should be an integral part of their operations.
They do understand the argument about the need for individuals
not to have a conflict of interest and therefore they have always
said that if one of the non-executive directors is involved at
an earlier stage in the appraisal process itself they should not
also chair the appeals panel. They have reiterated that and that
was included in the government response to your report. They still
think it is a perfectly proper role for a non-executive director
of NICE to chair an appeals panel in the sense that they are the
guarantor on behalf of the public of the independence and the
fair dealings of NICE.
Q69 Dr Taylor: So that change has
now been made and a non-executive takes the chair?
Dr Dobson: The Chairman is a non-executive
director. As I understand it they will have two distinct processes.
If an appeal is lodged a standing appeals committee will first
of all judge whether the appeal has merit prima facie and
whether it should go to an appeals panel, and they have decided
that the chair of the Standing Appeals Committee will be a non-executive
but not the Chairman of NICE. If a particular appeal is accepted
as having prima facie validity and goes to an appeals panel,
the appeals panel could still be chaired by the Chairman of NICE
if he had not had any previous involvement. That is my understanding
of it.
Q70 Dr Taylor: Going back for a moment
to the WHO review, it was actually very recent. It was June-July
2003. The BMJ did a leader on the report back in November and
by and large they welcomed the report. They said the report was
good but it was incomplete. One of the things they pointed out
that was lacking was that it did not answer the question. "What
impact does guidance from NICE have in practice on allocation
of resources and health outcomes at local levels?". I wonder
if you have any idea if there is yet any evidence that NICE guidance
is having an impact on clinical outcomes?
Lord Warner: I am not aware of
any but on the other hand we are talking about a pretty short
period of time from the first lot of technology appraisals and
we are talking about relatively small numbers. I will certainly
go back and check whether there is any evidence and I will talk
to NICE to see whether there is any evidence and come back to
the committee.
Q71 Dr Taylor: One minor measure
would be if there was a reduction in letters of complaint about
postcode rationing. Is that anything one could look into?
Lord Warner: I am certainly happy
to have a look into whether our correspondence mountain has changed
in the little bit around NICE implementation. I will certainly
look into that. It is a pretty unreliable measure.
Q72 Dr Taylor: It would at least
be interesting.
Lord Warner: I will see what we
can do.
In the absence of the Chairman, John Austin
was called to the chair
Q73 Jim Dowd: I want to speak in
particular about pharmaceutical issues. I was struck by Richard's
use of the phrase just now "postcode lottery" which
is bandied around in an almost self-evident fashion as if it is
a bad thing, but it relates to something you said earlier. How
do we reconcile the power to determine priorities locally with
an expectation that anybody anywhere in the country must have
the same range of treatments available to them?
Lord Warner: The straight answer
is, with the greatest difficulty. What we know with absolute confidence
is that where we tried to run the NHS in a much more centralised
manner we certainly did not achieve standardisation across the
whole country. We know that the evidence is that there were differences
of approach, different response times to particular treatments,
variability in access to treatments. All those things we know
from trying to run it in a very centralised manner. We also know
that we alienated quite a lot of people by trying to do it that
way, so we are moving to a situation in which the decision-making
is much more locally based. Where I think that takes you in terms
of the postcode lottery and variability in treatment responses
is that you rely on local mechanisms and you rely on PCTs and
providers to develop their relationships with communities and
patients' forums as to how well they are doing in responding to
those community needs. You have shifted the responsibility down
to the local level; that is the reality. At the same time one
is giving some broad strategic guidance from the centre and the
example of "Please implement NICE technology appraisals within
three months" is an example of that, except where NICE themselves
say, "There are good and sound reasons why it is not possible
to do that", not for financial reasons but for other reasons.
That is why I think it is probably right that NICE keep out of
the area of giving advice on resource issues because they are
meant to be above that battle. They are meant to be looking at
the merits of particular treatments in terms of cost effectiveness
and not skewing their advice in relation to the particular availability
of resources in particular areas.
Q74 Jim Dowd: But has it not also
generated an expectation that apart from deciding what the efficacy
or otherwise of a particular procedure or therapy is, once it
decides that this can be provided there is an expectation that
everybody can have that?
Lord Warner: I think we probably
have fed some public expectations there, but on the other hand
it would be fair to say that a bit of aspiration setting is the
way you drive up performance and practice in public services probably.
The journey can be a bit uncomfortable along the way.
Q75 Jim Dowd: To turn to the pharmaceutical
industry issues, the King's Fund, which of course is a research
establishment, not a research provider, presented a report late
last year—and I am not sure if you have had a chance to
look at it yet—on the relationship between the National
Health Service and the pharmaceutical companies and argued that
for too long the relationship has been uneven in so far as the
pharmaceutical companies themselves have driven the pace of development
and the Health Service has acted as a passive purchaser of their
products. How do you respond to that?
Lord Warner: One of the things
which has struck me in my eight months or so in the job is that
one is actually trying to do two things. One is trying to maintain
a very successful research based pharmaceutical industry in this
country which is second only to the US. I spend quite a lot of
my time going to EU meetings, more time than I would care even
to reflect upon, but one of the striking things is how well we
have done in maintaining that industry in this country compared
with one or two places in Europe. We have to hang on to that because
they are a very big driver of commercial R&D jobs. That is
that bit.
Q76 Jim Dowd: Is that because we
let them dictate the pace?
Lord Warner: I think we do not
let them dictate the pace unreasonably. You can argue that we
could do better in some particular areas, and I will come on to
one of the areas where we are keen to drive the agenda more strongly.
I do not think the King's Fund arguments are totally fair. They
make some arguments, as I understand it, about elderly people
having been neglected. If you just look at the NICE recommendations
I think there has been a good improvement in the quality and the
needs of elderly people being met through research based drugs
industries in areas like dementia drugs. Children's needs are
a slightly different situation but we do know that there is general
concern about whether there should be a more bespoke range of
drugs for children rather than modifying ad hoc drugs and that
is a concern across Europe and there is an initiative going on
in Europe and we are looking at the moment at not only tying into
that European initiative, where we are one of the drivers of it,
but at the same time seeing whether within the framework of European
legislation we can take some initiatives to incentivise the pharmaceutical
industry to move more rapidly along the path of bespoke paediatric
drugs. There are some levers which we are exploring. We have just
opened negotiations on the PPRS and that, in terms of research
incentives, may be an area we can use. We could look at some of
the regulatory fee systems to see whether we could give incentives
for particular types of drugs. We are trying to respond to some
of the spirit of the King's Fund report and try to identify areas,
in particular this children's area, where we could be, if you
like, a more active driver of the agenda.
Q77 Jim Dowd: I was going to come
on to the vulnerable groups they identified as not being best
served by the current arrangements. You mentioned children and
older people. The other group identified was women as not getting
a fair deal. Do you have any response to that?
Lord Warner: I do not have a response
on women. It is a bit hard to make the case outside the children's
area. Certainly for older people I do not think you could easily
make the case because a high proportion of drugs on the market
or in development have been developed particularly for that age
group. I will go away and look at what the evidence base is on
women and come back to you on that.
Q78 Jim Dowd: They suggest for dealing
with these perceived inequities, although I take your point that
you do not think the case is as monochromatic as they make out,
the establishment of a Health Research and Development Task Force.
Do you have anything to encourage them in that direction?
Lord Warner: As someone who is
trying to review and rationalise arm's length bodies, probably
setting up another arm's length body to go into this area is something
I would be a bit circumspect about. I am not sure that we do need
a task group. There are plenty of resources available for us to
draw upon in reviewing this particular area. We have a lot of
evidence from NICE on their work on drugs. We have the MHRA. We
have a lot of professional advice available to us. I think this
is a question of us looking at the evidence where I think it is
not good. Their arguments are not good on the elderly. I will
look again at the issue of women. We recognise there are problems
on children but I think you are going to have to find solutions
which are bespoke to particular kinds of groups if there is a
problem. That would be my take on the issue.
Q79 Jim Dowd: Finally, the steep
rise in the cost of some generic drugs in recent years: what is
the department doing to get better value for money for the NHS?
Lord Warner: You may know, and
I will send you the details if the committee does not know, that
we did take some action just before Christmas on four drugs which
have produced an annual saving of about £200 million. We
recognise that there are some issues around generics. We are on
that particular case. I cannot at this point give you further
and better particulars but we are looking very carefully at the
whole generics area. We are moving into an era when quite a lot
of drugs will come off patent so this will be an important issue
over the next few years. We are considering what action we might
take but if you look at what we did before Christmas you can see
that we are collecting the data and looking at that particular
issue.
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